AsiaIntervention最新文献

Background: Ultrathin-strut stents are considered the future of percutaneous coronary intervention for treating coronary artery disease (CAD). These drug-eluting stents with biodegradable-polymer technology have the potential to improve clinical outcomes in CAD patients.

Aims: This study aimed to evaluate the safety and performance of newer-generation ultrathin-strut (50 µm) Evermine50 everolimus-eluting stents (EES) in patients with single or multiple long lesions.

Methods: This is a prospective, single-arm, multicentre study conducted in India that enrolled 118 patients with de novo coronary lesions. The endpoints were defined based on the major adverse cardiac events (MACE; composite of cardiac death, myocardial infarction [MI] and clinically driven target lesion revascularisation) up to 24-month follow-up. A subset of patients (n=21) underwent angiographic follow-up for a mean follow-up period of 12 mon.

Results: A total of 138 lesions were successfully treated in 118 patients, the majority of whom were males (80.51%). The average stent length and diameter deployed were 26.02±9.24 mm and 2.97±0.36 mm, respectively. The results exhibited low MACE at 24-month follow-up (0.87%) with no stent thrombosis and 1 death (0.87%, which was cardiac). The core lab angiographic assessment showed in-segment and in-device late lumen loss of 0.12±0.31 mm and 0.17±0.31 mm, respectively, at a mean follow-up of 12 months, with clinically acceptable outcomes.

Conclusions: The Evermine50 EES showed satisfactory primary clinical as well as angiographic outcomes, reaffirming the safety and performance of the world's thinnest-strut stent by exhibiting low rates of MACE at 24-month follow-up with an absence of any stent thrombosis and MI. Clinical Trials Registry-India (CTRI) number: CTRI/2017/02/007781.

Background: Recent studies have shown potential in introducing machine learning (ML) algorithms to predict outcomes post-percutaneous coronary intervention (PCI).

Aims: We aimed to critically appraise current ML models' effectiveness as clinical tools to predict outcomes post-PCI.

Methods: Searches of four databases were conducted for articles published from the database inception date to 29 May 2021. Studies using ML to predict outcomes post-PCI were included. For individual post-PCI outcomes, measures of diagnostic accuracy were extracted. An adapted checklist comprising existing frameworks for new risk markers, diagnostic accuracy, prognostic tools and ML was used to critically appraise the included studies along the stages of the translational pathway: development, validation, and impact. Quality of training data and methods of dealing with missing data were evaluated.

Results: Twelve cohorts from 11 studies were included with a total of 4,943,425 patients. ML models performed with high diagnostic accuracy. However, there are concerns over the development of the ML models. Methods of dealing with missing data were problematic. Four studies did not discuss how missing data were handled. One study removed patients if any of the predictor variable data points were missing. Moreover, at the validation stage, only three studies externally validated the models presented. There could be concerns over the applicability of these models. None of the studies discussed the cost-effectiveness of implementing the models.

Conclusions: ML models show promise as a useful clinical adjunct to traditional risk stratification scores in predicting outcomes post-PCI. However, significant challenges need to be addressed before ML can be integrated into clinical practice.

Multivessel coronary artery disease (CAD), defined as ≥50% stenosis in 2 or more epicardial arteries, is associated with a high burden of morbidity and mortality in acute coronary syndrome (ACS) patients. A salient challenge for managing this cohort is selecting the optimal revascularisation strategy, for which the use of coronary physiology has been increasingly recognised. Fractional flow reserve (FFR) is an invasive, pressure wire-based, physiological index measuring the functional significance of coronary lesions. Understanding this can help practitioners evaluate which lesions could induce myocardial ischaemia and, thus, decide which vessels require urgent revascularisation. Non-hyperaemic physiology-based indices, such as instantaneous wave-free ratio (iFR), provide valid alternatives to FFR. While FFR and iFR are recommended by international guidelines in stable CAD, there is ongoing discussion regarding the role of physiology in patients with ACS and multivessel disease (MVD); growing evidence supports FFR use in the latter. Compelling findings show FFR-guided complete percutaneous coronary intervention (PCI) can reduce adverse cardiovascular events, mortality, and repeat revascularisations in ACS and MVD patients compared to angiography-based PCI. However, FFR is limited in identifying non-flow-limiting vulnerable plaques, which can disadvantage high-risk patients. Here, integrating coronary physiology assessment with intracoronary imaging in decision-making can improve outcomes and quality of life. Further research into novel physiology-based tools in ACS and MVD is needed. This review aims to highlight the key evidence surrounding the role of FFR and other functional indices in guiding PCI strategy in ACS and MVD patients.

Background: Although mortality after acute coronary syndrome (ACS) has improved in the acute phase, cardiovascular events occur at a certain frequency in the chronic phase. A hospital lipid-lowering protocol (HLP) could be effective in providing optimal lipid-lowering therapy to improve long-term clinical outcomes after ACS.

Aims: This study investigated the impact of HLP on clinical outcomes in patients with ACS.

Methods: We retrospectively analysed 1,114 ACS patients who had undergone successful percutaneous coronary intervention between November 2011 and June 2021. In December 2018, we introduced a HLP that included the prescription of the maximum tolerated dose of statin, ezetimibe, and eicosapentaenoic acid after ACS treatment. We compared 2-year clinical outcomes before (control group: 791 patients) and after the HLP's introduction (HLP group: 323 patients). The primary outcome was the non-target vessel revascularisation (non-TVR) rate. A multivariate Cox proportional hazard model and inverse probability weighting (IPW) based on the propensity score were used to evaluate the effect of HLP on the outcomes.

Results: The cumulative 2-year non-TVR incidence was significantly lower in the HLP group than in the control group (8.5% vs 13.8%; p=0.019). Multivariable analysis revealed non-TVR risk was significantly lower in the HLP group than in the control group (adjusted hazard ratio [aHR]: 0.637 [95% confidence interval [CI]: 0.416-0.975]; p=0.038). The IPW analysis confirmed a significant association between the HLP and a lower non-TVR risk (aHR: 0.544 [95% CI: 0.350-0.847]; p=0.007).

Conclusions: Implementing HLP for ACS patients improved the 2-year clinical outcome.

Background: The efficacy and safety of the ultrathin BioMime sirolimus-eluting coronary stent (SES) system in treating single or multiple de novo native coronary lesions, in-stent restenosis, and bifurcation lesions have been evidenced at 1 year.

Aims: We sought to investigate the long-term safety and efficacy of the BioMime SES in a real-world population with obstructive coronary artery disease (CAD).

Methods: The prospective, single-arm, multicentre meriT-2 trial enrolled 250 patients from 11 sites across India. The safety endpoint was the cumulative frequency of major adverse cardiovascular events (MACE) at 5 years, defined as a composite of cardiac death, myocardial infarction (MI), emergent coronary artery bypass grafting or clinically indicated target lesion revascularisation (CI-TLR). Stent thrombosis (ST) was evaluated according to the Academic Research Consortium definitions.

Results: A total of 214 (85.6%) subjects completed the 5-year follow-up. The mean age of patients was 57.44±10.75 years, and 82.71% were males. A total of 308 lesions were treated with BioMime SES. Most of the lesions were localised in the left anterior descending artery (45.46%) and were type B2 lesions (44.81%). The cumulative MACE rate at 5 years was 8.9% (n=19), including 0.9% cardiac deaths, 1.9% MI and 6.1% CI-TLR. The rate of ST was only 0.5%. The Kaplan-Meier survivor analysis revealed actuarial survivorship of 95.6% for the intention-to-treat population (n=250) over 5 years.

Conclusions: The long-term clinical outcomes of the meriT-2 trial established the safety and efficacy of the ultrathin-strut biodegradable-polymer-based BioMime SES with satisfactory clinical outcomes at 5 years.

Background: The hybrid strategy of drug-eluting stent (DES) and drug-coated balloon (DCB) has been increasingly accepted for the treatment of de novo coronary artery disease. However, data regarding the clinical outcome of this practice in a Southeast Asian population are limited.

Aims: We aimed to investigate the safety and clinical outcome of this hybrid strategy (DES and DCB) in the treatment of de novo coronary artery disease. The primary endpoint was target lesion failure (TLF) in the DES/DCB-treated segment at 12 months. TLF is defined as the composite of cardiac death, target vessel myocardial infarction (TVMI) and ischaemia-driven target lesion revascularisation (ID-TLR) in the DES- and/or DCB-treated segment.

Methods: A total of 401 patients with 458 lesions were treated with the hybrid strategy at the National Heart Institute (IJN), Kuala Lumpur, Malaysia, from 1 July 2021 to 30 June 2022, were retrospectively enrolled in the study. A total of 38 patients (9.5%) were lost to subsequent follow-up, and the remaining 363 patients (90.5%) were included in the outcome analysis. Clinical outcomes at 1 year were analysed.

Results: In all, 219 lesions (47.8%) involved the left anterior descending artery, 146 lesions (31.9%) involved the right coronary artery, and 57 lesions (12.4%) involved the left circumflex artery. In all, 87 lesions (19%) were bifurcation lesions. A total of 8 patients (2.2%) had TLF, of whom 3 patients (0.83%) had TVMI, 3 patients (0.83%) had ID-TLR, and 2 patients (0.6%) experienced cardiac death. Four patients died of a non-cardiac cause at 1-year follow-up.

Conclusions: A hybrid strategy of DES and DCB for the treatment of de novo coronary artery lesions appears to be feasible and clinically safe according to the 1-year outcomes.